Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00056589
First received: March 18, 2003
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.


Condition Intervention Phase
Congenital Bleeding Disorder
Congenital FXIII Deficiency
Drug: catridecacog
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of clinically significant changes from baseline in physical examination or laboratory measurements [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
  • Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
  • Incidence of yeast antibodies [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
  • FXIII activity measured by the Berichrom® assay [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: March 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFXIII Drug: catridecacog
Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documental congenital FXIII deficiency
  • Normal platelet count and clotting parameters
  • Adequate renal and hepatic function
  • If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
  • If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
  • Negative drug and alcohol screens

Exclusion Criteria:

  • Received blood products or FXIII concentrates within 4 weeks of study enrollment
  • Known antibodies to FXIII
  • Hereditary or acquired coagulation disorder other than FXIII deficiency
  • Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
  • Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
  • Received treatment with any experimental agent within 30 days of study enrollment
  • Any surgical procedure in the 30 days prior to enrollment
  • Donated blood within 30 days prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056589

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00056589     History of Changes
Other Study ID Numbers: F13-1663
Study First Received: March 18, 2003
Last Updated: November 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Factor XIII Deficiency
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014